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Clinical Trials (2nd Ed.) Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Langue : Anglais

Auteur :

Couverture de l’ouvrage Clinical Trials
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices.

Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.
- 1. The Origins of Drugs
- 2. Introduction to Clinical Trial Design
- 3. Run-in Period
- 4. Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I
- 5. Inclusion and Stratification Criteria – Part II
- 6. Randomization, Allocation, and Binding
- 7. Intent to Treat Analysis vs. Per Protocol Analysis
- 8. Biostatistics – Part I
- 9. Biostatistics – Part II
- 10. Introduction to Endpoints for Clinical Trials in Pharmacology
- 11. Endpoints in Clinical Trials on Solid Tumors – Objective Response
- 12. Oncology Endpoints: Overall Survival and Profession-Free Survival
- 13. Oncology Endpoints:  Time to Progression
- 14. Oncology Endpoint: Disease-Free Survival
- 15. Oncology Endpoint: Time to Distant Metastasis
- 16. Neoadjuvant Therapy vs. Adjuvant Therapy
- 17. Hematological Cancers
- 18. Biomarkers and Personalized Medicine
- 19. Endpoints in Immune Diseases
- 20. Endpoints in Clinical Trials on Infections
- 21. Health-Related Quality of Life
- 22. Health-Related Quality of Life Instruments for Immune Disorders
- 23. Health-Related Quality of Life Instruments and Infections
- 24. Drug Safety
- 25. Mechanisms of Action, Part I
- 26. Mechanisms of Action, Part II – Cancer
- 27. Mechanisms of Action, Part III – Immune Disorders
- 28. Mechanisms of Action, Part IV- Infections
- 29. Consent Forms
- 30. Package Inserts
- 31. Regulatory Approval
- 32. Patent
Researchers, physicians, nurses, pharmacists who plan and run clinical trials, members of the American Medical Writers Association, pharmaceutical and biotechnology industry scientists, pharmacology and pharmaceutical science students, pharmacy students and medical students
Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C.

Date de parution :

Ouvrage de 863 p.

19.1x23.5 cm

Disponible chez l'éditeur (délai d'approvisionnement : 14 jours).

88,31 €

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